ADME Processes in Pharmaceutical Sciences: Dosage, Design, and Pharmacotherapy Success

364 Pages·2018·8.424 MB·English

by  Alan Talevi, Pablo A. M. Quiroga

Alan Talevi
Pablo A. M. Quiroga
Editors
ADME Processes
in Pharmaceutical
Sciences
Dosage, Design,
and Pharmacotherapy Success
ADME Processes in Pharmaceutical Sciences
(cid:129)
Alan Talevi Pablo A. M. Quiroga
Editors
ADME Processes
in Pharmaceutical
Sciences
Dosage, Design,
and Pharmacotherapy Success
Editors
AlanTalevi PabloA.M.Quiroga
LaboratoryofBioactiveResearchand QualityControlofPharmaceuticalProducts,
Development(LIDeB),Departmentof PharmaceuticalToxicology,Departmentof
BiologicalSciences,FacultyofExact BiologicalSciences,FacultyofExactSciences
Sciences UniversidadNacionaldeLaPlata
UniversityofLaPlata(UNLP) LaPlata,BuenosAires,Argentina
LaPlata,BuenosAires,Argentina
DepartmentofPharmacologicalResearch
ConsejoNacionaldeInvestigaciones LaboratoriosBagóS.A.
CientíficasyTécnicas(CONICET) LaPlata,BuenosAires,Argentina
LaPlata,BuenosAires,Argentina
ISBN978-3-319-99592-2 ISBN978-3-319-99593-9 (eBook)
https://doi.org/10.1007/978-3-319-99593-9
LibraryofCongressControlNumber:2018965237
#SpringerNatureSwitzerlandAG2018
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A.Talevi dedicates this volumetohis parents,
his grandmother, and Ana Paula.
P. Quiroga would like to dedicate this book
to his parents, Juan Manuel, Marcelo,
María Guillermina and Marta.
Preface
For quite a long time, pharmacokinetics was taught as one or two units within
pharmacology courses. Today, due to their specific importance, biopharmaceutics
and pharmacokinetics are taught as an independent course in every school of
pharmacy worldwide, with applications in a diversity of areas and disciplines,
from clinical practice to drug discovery, from molecular biology to material
sciences. Owing to their impressive and continuous growth, some topics from the
field of pharmacokinetics (such as drug metabolism or drug transporters) currently
deserveentirespecializedvolumes.
This book has been conceived as an introduction to pharmacokinetics for phar-
macyandmedicinestudents,butalsoforprofessionalsfromotherfieldscircumstan-
tiallyworkinginrelationtopharmaceuticalsciences,includingchemists,physicists,
bioengineers,andmolecularbiologists.
This volume is structured in two parts. The first part is dedicated to a classic
presentation of absorption, distribution, metabolism, and excretion processes and
routes of administration, with an emphasis on qualitative and biological aspects of
suchtopics,casereportsdiscussion,andexamples.Thesecondpartisdedicatedto
burgeoning topics associated to pharmacokinetics, including pharmaceutical
nanocarriers,pharmacokineticsofbiologicalmedicalproducts,pharmacogenomics,
bioequivalence studies, drug-drug interactions of pharmacokinetic origin, in vitro
and in silico ADME predictions, and drug transporters. The authors come from a
diversity of professional areas and include experienced academicians, qualified
clinical practitioners, industry professionals, and experts from regulatory agencies.
We are proud to count, within the volume contributors, experts from Duquesne
University, Indiana University, University of Utah, University of Maryland, and
UniversityofBath,amongothers.
The editors are thankful to all the people who have made this volume possible.
First, we thank all the invited authors who have contributed with their expertise to
createauthoritativeandstimulatingchaptersforthesecondpartofthisvolume.We
would also like to express our thanks to the editorial team, especially to Carolyn
SpenceandJayashreeDhakshnamoorthy,whohavealwaysbeenavailabletomake
our job as editors as easy and pleasant as possible, providing valuable advice and
assistance.
vii
viii Preface
Wehopethatthisbookwillserveasausefulresourcefornewcomersinthefield
of pharmacokinetics and pharmacology, but also to practicing scientists currently
workingintheexcitingfieldofdrugdiscoveryanddevelopment.Wealsohopewe
havesucceededinmakingthisvolumeapleasant,didactic,andclearintroductionto
thewonderful,vastworldofpharmacokinetics.
LaPlata,BuenosAires,Argentina AlanTalevi
PabloA.M.Quiroga
Contents
PartI TheBasicsofADMEProcesses
1 Introduction.BiopharmaceuticsandPharmacokinetics. . . . . . . . . 3
AlanTaleviandPabloA.M.Quiroga
2 DrugAbsorption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
AlanTaleviandCarolinaLeticiaBellera
3 DrugDistribution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
AlanTaleviandCarolinaLeticiaBellera
4 DrugMetabolism.. . . . .. . . . .. . . . .. . . . .. . . . .. . . . .. . . . .. . 55
AlanTaleviandCarolinaLeticiaBellera
5 DrugExcretion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
AlanTaleviandCarolinaLeticiaBellera
6 RoutesofDrugAdministration. . . . . . . . . . . . . . . . . . . . . . . . . . . 97
MaríaEsperanzaRuizandSebastiánScioliMontoto
7 NanotechnologyandDrugDelivery. . . . . . . . . . . . . . . . . . . . . . . . 135
GermánAbelIslan,SergioMartin-Saldaña,MerariTuminChevalier,
VeraAlejandraAlvarez,andGuillermoRaúlCastro
PartII TheImportanceofADMEPropertiesinBurgeoning
PharmaceuticalTopics
8 RelationshipBetweenPharmacokineticsand
PharmacogenomicsandItsImpactonDrugChoice
andDoseRegimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
MatíasF.MartínezandLuisA.Quiñones
9 TheRelationshipBetweenPharmacogenomicsand
PharmacokineticsandItsImpactonDrugChoiceand
DosingRegimensinPediatrics. . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
VenkataK.Yellepeddi,JessicaK.Roberts,LeslieEscobar,
CaseySayre,andCatherineM.Sherwin
ix
x Contents
10 BioavailabilityandBioequivalence. . . . . . . . . . . . . . . . . . . . . . . . . 223
Z.GulsenOnerandJamesE.Polli
11 Absorption,Distribution,Metabolism,andExcretion
ofBiopharmaceuticalDrugProducts. . .. . . .. . . .. . . .. . . .. . . .. 241
MollyGravenoandRobertE.Stratford,Jr.
12 Drug-DrugandFood-DrugInteractions
ofPharmacokineticNature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
PietroFagiolino,MartaVázquez,ManuelIbarra,
CeciliaMaldonado,andRosaEiraldi
13 InVitroandInSilicoADMEPrediction. . . . . . . . . . . . . . . . . . . . . 301
AngelaEffinger,CaitrionaM.O’Driscoll,MarkMcAllister,
andNikolettaFotaki
14 DrugTransporters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
AlanTalevi,CarolinaLeticiaBellera,andGuidoPesce
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
Part I
The Basics of ADME Processes